Application Software Testing
As a global leader specializing in providing a full scope of validation services for computer systems, software, and medical devices within pharmaceutical, medical device and biotechnology companies worldwide, Arbour Group L.L.C. understands the mission-critical importance of having a fully capable verification and validation process. Our validation professionals are thoroughly familiar with the current FDA requirements for validation and have the technical expertise, the management foresight and the international support systems to help our clients ensure that all elements of the testing process are validated in compliance with applicable regulations to minimize their business risk and to enhance their ability to compete successfully in the marketplace.
The Application Software Testing professionals at Arbour Group have industry experience in software development, project management and software and systems testing to provide assurance that our client's products will be tested to be compliant with regulatory requirements, including cGMPs (21 CFR Part 211), Quality Systems Regulations (21 CFR Part 820), Electronic Records and Signatures (21 CFR Part 11), and FDA Guidelines, as they impact software applications created in the client's software development process. They focus not only on industry and regulatory requirements, but on user needs, system functionality and structural and behavioral considerations as well.
Arbour Group's approach to Application Software Testing is based on the ability to function as an integral part of the client's project team. Our experienced professionals are equipped to analyze, plan and execute the appropriate testing methodologies to meet the client's goals and objectives and help in delivering high quality products that respond effectively to customer needs and compliance requirements. The process of Application Software Testing follows a logical and time-proven sequence of events:
Project Planning - capture product requirements and specifications, plan structured testing phases, determine critical test areas and risk reduction options, prepare test plan, schedule within project goals
Test Development - establish test protocol, create test cases corresponding to each product requirement and specification, formulate traceability matrix and develop error-tracking systems
Test Execution - conduct routine test meetings and promulgate appropriate communications, perform operational, functional and stress tests, implement error-tracking systems, launch test case studies and perform additional tests based on results
Testing Tools - select and use automated stress test cycling, code coverage analysis and proprietary and commercial testing tools
Test Deliverables - complete traceability matrix, present test case results and report on testing metrics
Our results-oriented Application Software Testing process not only assures compliance and functionality, but also responds competitively to the needs of customers by ensuring product quality and reliability.
